New FDA Head's First Order of Business: Inspection Staff Reorg and Lower Drug Prices
May 16, 2017
By Mark Terry, BioSpace.com Breaking News Staff
The new U.S. Food and Drug Administration Commissioner Scott Gottlieb hit the ground running with an all-staff meeting at the agency to lay out his priorities and goals.
For the most part, there didn’t seem to be major changes in store, and some of them were in the works for years. Some of the discussion focused on health initiatives such as smoking and the opioid epidemic. One comment Gottlieb made that is likely to get the attention of the biopharma industry revolves around drug pricing. He said, “I know FDA doesn’t play a direct role in drug pricing. But we still need to be taking meaningful steps to get more low cost alternatives to the market, to increase competition, and to give consumers more options.”
No details, however, were outlined.
John Carroll, writing for Endpoints News, noted, “Gottlieb pledged to find new ways to lower drug prices, pushing through complex generics and biosimilars while laying the groundwork to prevent any more sweetheart deals to delay the arrival of low-cost knockoffs, implying that he’s preparing to take action on that front.”
Gottlieb also said, “Congress gave us a clear mandate to be forward-leaning when it comes to how we’ll evaluate safety and efficacy in view of emerging scientific insight and better analytical tools. Implementing the 21st Century Cures Act is a key priority. We need to make sure we’re taking steps to foster innovation and regulating areas of promising new technology in ways that don’t raise the cost of development or reduce innovation.”
One more concrete change Gottlieb outlined is to the FDA’s Office of Regulatory Affairs (ORA). To date, the ORA’s activities were focused on U.S. geographic regions. The ORA has 4,000 staffers that investigate consumer complaints, oversee imported products, and inspects domestic and foreign drug manufacturing and research facilities to ensure compliance. The ORA will shift over to overseeing specific product areas such as pharmaceuticals or medical devices.
This initiative isn’t new to Gottlieb. It was proposed four years ago. Implementation will begin this month. Gottlieb said in a memo that it “will make our field programs more modern and responsive to today’s threats and challenges, while making sure that we are taking a risk-based and science-based approach to our work. We need to make sure that we are achieving the greatest degree of consumer protection with the resources that we have.”
The ORA had 20 district offices that reported to five region heads. The restructuring will have the staff report to six product-specific offices: pharmaceutical quality, medical devices, tobacco, food, biologic drugs, and research. Bloomberg notes, “Employees who work on imported products will continue to oversee all types of FDA-regulated goods, while the agency’s 13 labs around the country will become more focused on specific challenges focusing on either food or medical products, tobacco and specialty, according to the memo.”
It will also make it easier for the FDA to implement the Food Safety Modernization Act, which was signed by President Barack Obama in 2011.
Carroll writes, “None of this is a dramatic departure for the FDA. But Gottlieb is also sending the message that business as usual won’t be the theme for his tenure as head of the FDA.”